摘要
目的评价莉芙敏片（黑升麻根茎异丙醇提取物）与替勃龙治疗妇女围绝经期症状的疗效和安全性。方法以多中心、随机、双盲、双模拟、平行对照研究方法，入组40～60岁的绝经期妇女180例，按1：1分配至莉芙敏片组和替勃龙组，各90例。莉芙敏片组口服莉芙敏片20mg，每日2次，替勃龙组口服替勃龙2．5mg／d，连续用药12周。以Kupperman绝经期指数（KMI）总分为主要疗效指标，以KMI各单项指标作为次要疗效指标，在治疗前、治疗4、12周时进行观察，以肝肾功能、血常规等实验室检查项目及不良事件作为安全性指标，对用药前后进行组间、组内比较。结果（1）KMI总分：治疗前KMI总分莉芙敏片组为（24±5）分，替勃龙组为（25±6）分；治疗4周时，KMI总分莉芙敏片组为（11±6）分，替勃龙组为（11±7）分；治疗12周时，KMI总分莉芙敏片组为（7±6）分，替勃龙组为（6±5）分。各时间点两组KMI总分比较，差异均无统计学意义（P〉0．05）。（2）KMI各单项指标：两组内治疗前与治疗4、12周时各项症状评分比较，差异有统计学意义（P〈0．05）；但治疗后各时间点各指标在两组间比较，差异无统计学意义（P〉0．05）。（3）不良事件：莉芙敏片组与研究药物有关的不良事件发生率显著低于替勃龙组；莉芙敏片组无一例阴道出血，替勃龙组阴道出血17例（19％，17／90）；莉芙敏片组乳房胀痛14例（16％，14／90），替勃龙组32例（36％，32／90）；治疗前子宫内膜厚度莉芙敏片组为（2．6±1．1）mm，替勃龙组为（2．8±1．1）mm，治疗12周时，子宫内膜厚度莉芙敏片组为（2．9±1．4）mm，替勃龙组为（3．4±2．0）mm，治疗前与治疗12周时比较，莉芙敏片组子宫内膜厚度无明显增厚，而替勃龙组子宫内膜厚度明显增加。结论莉芙敏片能够有效、安全地改善妇女的围绝经期症状，其疗效与替勃龙相似，不良事件发生率低于替勃龙。
Objective To investigate the efficacy and safety of remifemin （isopropanolic extract of cimicifuga racemosa） treating perimenopausal symptoms in comparison of tibolone. Methods One hundred and eighty postmenopausal women at range of 40- 60 years old were enrolled in a multicenter, randomized and double blind study. They were divided into remifemin and tibolone group at ratio 1： 1. The therapeutic strategy was remifemin 20 mg bid po for 12 weeks in remifemin group and tibolone 2. 5 mg qd po for 12 weeks in tibolone group. To evaluate therapeutic effect, total score of Kupperman menopause index （KMI） was used as the major observed index and single item score of KMI were secondary observed index. Safety warning was determined by laboratory tests and adverse events at timepoint of before, at 4 and 12 weeks treatment. Results （ 1 ） Total score of KMI： it were 24± 5 in remifemin group and 25± 6 in tibolone group before treatment. At timepoint of 4 weeks treatment, it were 11 ±6 in remifemin group and 11 ±7 in tibolone group. At timepoint of 12 weeks treatment, it were 7±6 in remifemin group and 6±5 in tibolone group. Total KMI score between two groups did not show statistical difference at various timepoint （P 〉0. 05）. （2） Single item score of KMI- when compared before, at 4 and 12 weeks treatment, did show remarkable difference （ P 〈 0.05 ） either in remifemin or in tibolone group. However, those single items of KMI score did not show statistical difference between 4 and 12 weeks timepoint in each treatment group （P 〉 0. 05）. （3） Adverse effect： the incidence of adverse effect in remifemin group was significantly lower than that of tibolone group. None case with vaginal bleeding was observed in remifemin group, however, 17 cases with vaginal bleeding occurred in tibolone group（ 19%, 17/90）. The incidence of breast swelling were 16% （14/90） in remifemin group and 36% （32/90） in tibolone group; before treatment, the thickness of endometrium were （2. 6 ~ 1.1 ）mm in remifemin group and （2. 8 ± 1.1 ）mm in tibolone group ; at timepoint of 12 weeks treatment, the thickness of endometrium were （2. 9 ± 1.4） mm in remifemin group and （3.4 v 2. 0） mm in tibolone group. In comparison of thickness of endometrium before and at 12 weeks treatment, no remarkable changes was observed in remifemin group, however, endometrium displayed significantly thicker in tibolone group. Conclusions Our study suggested that remifemin was one effective and safe agent to manage women with climacteric symptom. It has similar therapeutic effect and lower incidence of adverse effect when compared with tibolone.
出处
《中华妇产科杂志》
CAS
CSCD
北大核心
2009年第8期597-600,共4页
Chinese Journal of Obstetrics and Gynecology
基金
基金项目：北京大学医学部“985工程”二期建设项目（985-2-015-24）
